On a roll about the PACE trial, aren’t I 😉
It’s first thing in the morning, I’m still in bed and I’ve started to write. This is the only time of the day when my brain works well. Usually I wouldn’t do anything right now, except having a bath and getting dressed, saving energy for the day ahead, but the issues around the PACE trial are getting me so fired up that today I’m going to write again.
The importance of knowing how research works
Research design is very expert. Really it is. You can’t just bang out a few questions on a form and ask a few people some questions, you have to really know your stuff.
As I said in this post, I’ve got a post-grad in Psychology. I’ve carried out research too. Believe me, if you think Psychology is a fluffy subject which is all about peeeeple, man, it isn’t.
Studying Psychology was the biggest, hardest learning curve I’ve ever had in learning about how research is carried out. All the way through the course that I did, research was underpinning the curriculum, so I had to learn about research methods and statistics and how to critique those research methods too.
All Clinical Psychologists working in the NHS in the UK are required to enter the training for the profession with a qualification in Psychology. They then train to be Clinical Psychologists (CP’s).
Research underpins that profession and as I explained in yesterday’s post, those CP’s who do CBT in NHS CFSME clinics will have a similar level of training in looking at research and how to carry it out.
Psychology is so much about research, it’s very research-intensive. This means that CP’s will be completely on the ball about how to carry it out.
Cognitive Behavioural Therapy & Research
As I said in yesterday’s post, CBT requires practitioners to record patient symptoms and thoughts and feelings using tailor-made scales throughout their treatment.
It’s this inbuilt ‘research-style’ of recording that means that research into the efficacy of CBT is much more represented in research into therapeutic efficacy, than any other form of therapy in the UK.
By ‘therapy’ I mean therapy and counselling. By ‘efficacy’ I mean whether it works or not and with whom.
Health research – the political bit (small p)
The preponderance of research into CBT and supporting CBT does not mean that it is any more or less effective than any other form of therapeutic intervention, it simply means there is more research that has been carried out and published into it than other forms of therapy and counselling.
In 2008** the NHS started to formally require counsellors and therapists working in it, to evidence the outcomes associated with their practice. That means that whereas before then you could say that someone’s symptoms were definitely better and that was enough, afterwards you had to PROVE it.
CBT could put their hands on this quickly
Because CBT has a process built into it that evidenced changes of thoughts and behaviour, the CBT therapists were far better at putting their hands on that evidence and providing it, as soon as it was asked for.
They were also far better at setting up means and methods of doing research studies into the efficacy of CBT which then, I noticed at the time, started to be published with startling regularity in the clinical press.
At the time I was employed to research the efficacy of the type of Psychodynamic Psychotherapy that I was practicing. It was very difficult to do. I noticed that as I was struggling with how to meet the NHS directives, my colleagues who were practicing CBT were streets ahead.
It seemed to me that because research into CBT had been published so often, it was almost as if it was the only therapeutic intervention that existed in the eyes of the journals. Also, it turned out, in the eyes of the NHS.
CBT had proved it worked! Courses started to be set up! They weren’t now requiring someone to be a CP to practice them either, and all through this sea change, the NHS language altered.
The language about CBT changed to: “It’s very effective in treating….XY and Z” and there was a cast iron certainty about it.
I was left feeling a sense of disquiet though – how could commissioners say that it worked any better or worse than other therapeutic interventions when the other interventions were still struggling to produce the evidence that was required.
A lack of evidence didn’t mean other types of treatment didn’t work, if you see what I mean.
What’s a confounding variable?
A confounding variable is something that intrudes on your research that often you didn’t see coming when you designed it.
So, for instance, you are doing research into how effective CBT is with hard-to-engage patients with long term mental health issues. You design it with the research team and you carry it out.
Voila! Your research data comes back. You are sifting it, running it through statistical analysis tools, you are discussing it with your colleagues and you are starting to write the academic paper for publication.
Then one bright spark in your team mentions that some of the people who were in the research said that they really liked coming for the treatment because they got cafe vouchers that meant they could have a slap up 3 course meal for free.
This was provided by the hospital because they were on benefits and it was a part of the service the hospital offers to all patients on benefits.
The team go silent, pondering this information. Someone eventually says what everyone is thinking. “Dammit, we’ve got a confounding variable…”and everyone busies themselves thinking about how to write this into the research paper to show that it’s been considered.
It affects the research validity, you see, because the voucher for the free lunch may have unnaturally affected the way the participants felt about or responded to the treatment. It’s a weakness in the research.
This fictional example is rather like the newsletter that was sent out to PACE trial participants.
Commentators have pointed out that this newsletter which contained positive messages about the treatment, could have also unnaturally influenced the attitudes of the people in the PACE trial. It was a confounding variable for this reason.
I think there were others……
I’ve said many times that I’ve been a patient at an NHS CFSME clinic. I know an awful lot of people who’ve also been patients at that clinic and others too. Yesterday over Twitter more people were talking about their experiences from across the country.
One of the things I felt when I was referred for treatment was how bloody desperate I was to find anything at all that would make me feel better.
I was absolutely desperate. By the time I’d been told by my GP that it was essential for me to increase my activity levels due to having a new pre-diabetic diagnosis, I’d have tried anything, and I did.
I tried Graded Exercise Therapy.
Beforehand I didn’t even consider GET because I had read all about it and wasn’t certain it was going to be a safe treatment. However I was desperate, and, it’s worth saying, the 3 treatments on offer at the NHS CFS ME clinic I attended were:
- CFS Management Group (CMG)
That’s it. So I was sort-of caught in a loop of knowing that if I wanted any treatment at all, I’d have to go for one of those 3.
That and the desperation I felt pushed me into doing GET. This was about a year after trying and failing to continue with the CFS group that increased my pay back symptoms so much, I crashed – and I wasn’t evaluated, as I said here.
Other people have spoken to me about that sense of desperation as well.
My friend, CB is one. She said she did the CMG because she felt she had no choice – she was clutching at straws and felt it might be the life raft she needed. It wasn’t the life raft she needed because she said she’s never acted on anything they said there, but she liked the feeling of doing something constructive about her health. She felt she could tick it off the list of options she’d tried after 25 years of having CFSME.
And she’s not the only one. Some people explained to me that they tried CBT or GET for the same reasons. “I was desperate” is a common theme, whether they completed the treatment or not, and whether they said it was successful and worked for them, or not.
Of all the people I’ve ever spoken to about this, by the way, only 1 person came away with a positive experience and I wrote about this in a post with their permission some time ago. There are obviously others but I haven’t spoken to them to give their view here.
Here’s where I think this is important – and a potential confounding variable in the PACE trial.
Patient motivation is very important to understand for why they access or adhere to therapeutic treatment.
In my fictional example, above, the confounding variable was the free 3 course lunch.
I think there’s a potential research study into the motivations of patients accessing CFSME clinics and then choosing treatment. In the PACE trial we don’t know how many of those who was in the research had got to the point of desperation and that influenced their compliance and willingness to accept that the treatment worked.
We don’t know because the research didn’t ask questions about patient motivation.
If it did, and was introduced into the statistical analysis of the research findings we could discover if there was a link between motivation and therapeutic outcomes….we could then fine tune for which population of patients the combination of GET and CBT works best – possibly those who are ‘desperate’.
The Lightning Process is the only therapeutic treatment which asks specific questions of the client’s motivation and commitment to the treatment before someone is ‘passed’ as being suitable for attendance.
With the Bath SMILE study including The Lightning Process, will patient motivation be one aspect that is discussed in the final research paper? We don’t know yet, it isn’t complete.
One thing I would say though – if the PACE trial newsletter was considered to be positively skewing the results, what can naming a trial SMILE do? A smile is positive, it is friendly, it is welcoming….it is a word with prosody (emotional meaning).
Post-PACE, could naming a research study SMILE also be considered a confounding variable in their results?
© Lindy 2015
** addendum 17/11/15: NHS guidelines about evidencing therapeutic outcomes changed in 1998, directly after the change of government in 1997. It wasn’t 2008.
By 2008 the 10 years-or-so of research evidence into CBT had taken hold and was consistently represented in the research literature.This created a sense of confidence in it as a form of therapy and the ripple effect touched clinical training, clinical commissioning and, I believe, confidence in PACE trial outcomes.
I have brain fog. It affects the way I think, speak, recall and remember. I also don’t spot mistakes like these when they’ve happened because my mind isn’t working properly. It’s something I live with, having MECFS.